Landmark analysis after 3 months and 6 months
| Three-month landmark . | Treatment change after 3 mo . | FFS after 3 mo . | NRM after 3 mo . | OS after 3 mo . |
|---|---|---|---|---|
| NIH calculated (2005) | P = .37 | P = .49 | P = .55 | P = .51 |
| CR + PR vs SD + PD | ||||
| NIH calculated (2014) | HR 0.50 (0.30-0.80) | HR 0.60 (0.41-0.89) | P = .32 | P = .59 |
| CR + PR vs SD + PD | P = .003 | P = .01 | ||
| Clinician reported | HR 0.28 (0.18-0.47) | HR 0.34 (0.22-0.52) | P = .84 | P = .47 |
| CR + PR vs SD + PD | P < .001 | P < .001 | ||
| Patient-reported improvement (I) vs stable (S) vs worsening (W) | Overall P < .001 | Overall P < .001 | P = .62 | P = .36 |
| I vs S | HR 0.41 (0.24-0.74), P = .002 | HR 0.43 (0.27-0.70), P < .001 | ||
| S vs W | HR 0.24 (0.10-0.69), P = .003 | HR 0.25 (0.11-0.63), P = .001 |
| Three-month landmark . | Treatment change after 3 mo . | FFS after 3 mo . | NRM after 3 mo . | OS after 3 mo . |
|---|---|---|---|---|
| NIH calculated (2005) | P = .37 | P = .49 | P = .55 | P = .51 |
| CR + PR vs SD + PD | ||||
| NIH calculated (2014) | HR 0.50 (0.30-0.80) | HR 0.60 (0.41-0.89) | P = .32 | P = .59 |
| CR + PR vs SD + PD | P = .003 | P = .01 | ||
| Clinician reported | HR 0.28 (0.18-0.47) | HR 0.34 (0.22-0.52) | P = .84 | P = .47 |
| CR + PR vs SD + PD | P < .001 | P < .001 | ||
| Patient-reported improvement (I) vs stable (S) vs worsening (W) | Overall P < .001 | Overall P < .001 | P = .62 | P = .36 |
| I vs S | HR 0.41 (0.24-0.74), P = .002 | HR 0.43 (0.27-0.70), P < .001 | ||
| S vs W | HR 0.24 (0.10-0.69), P = .003 | HR 0.25 (0.11-0.63), P = .001 |
| Six-month landmark . | Treatment change after 6 mo . | FFS after 6 mo . | NRM after 6 mo . | OS after 6 mo . |
|---|---|---|---|---|
| NIH calculated (2005) | HR 0.61 (0.40-0.90) | P = .06 | P = .24 | P = .06 |
| CR + PR vs SD + PD | P = .01 | |||
| NIH calculated (2014) | HR 0.56 (0.37-0.83) | HR 0.58 (0.42-0.80) | P = .28 | P = .20 |
| CR + PR vs SD + PD | P = .003 | P = .001 | ||
| Clinician reported | HR 0.53 (0.36-0.81) | HR 0.61 (0.44-0.85) | P = .06 | HR 0.55 (0.36-0.85) |
| CR + PR vs SD + PD | P = .004 | P = .004 | P = .007 | |
| Patient-reported improvement vs stable vs worsening | P = .13 | P = .08 | P = .33 | P = .44 |
| Six-month landmark . | Treatment change after 6 mo . | FFS after 6 mo . | NRM after 6 mo . | OS after 6 mo . |
|---|---|---|---|---|
| NIH calculated (2005) | HR 0.61 (0.40-0.90) | P = .06 | P = .24 | P = .06 |
| CR + PR vs SD + PD | P = .01 | |||
| NIH calculated (2014) | HR 0.56 (0.37-0.83) | HR 0.58 (0.42-0.80) | P = .28 | P = .20 |
| CR + PR vs SD + PD | P = .003 | P = .001 | ||
| Clinician reported | HR 0.53 (0.36-0.81) | HR 0.61 (0.44-0.85) | P = .06 | HR 0.55 (0.36-0.85) |
| CR + PR vs SD + PD | P = .004 | P = .004 | P = .007 | |
| Patient-reported improvement vs stable vs worsening | P = .13 | P = .08 | P = .33 | P = .44 |
HR, hazard ratio.